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Deep Brain Stimulation of Nucleus Accumbens to Treat Severe Anorexia Nervosa

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ClinicalTrials.gov Identifier: NCT02593695
Recruitment Status : Unknown
Verified November 2015 by Guodong Gao, Tang-Du Hospital.
Recruitment status was:  Active, not recruiting
First Posted : November 2, 2015
Last Update Posted : November 10, 2015
Sponsor:
Information provided by (Responsible Party):
Guodong Gao, Tang-Du Hospital

Brief Summary:
Anorexia nervosa (AN) is a complex and severe psychiatric disorder with high relapse rates under standard treatment.Deep brain stimulation (DBS) may be a novel treatment in severe Anorexia nervosa.

Condition or disease Intervention/treatment Phase
Anorexia Nervosa Procedure: Deep brain stimulation Other: Fluoxetine Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 10 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Deep Brain Stimulation of Nucleus Accumbens as a New Treatment to Treat Severe Anorexia Nervosa
Study Start Date : October 2015
Estimated Primary Completion Date : December 2017
Estimated Study Completion Date : December 2017

Resource links provided by the National Library of Medicine

Drug Information available for: Fluoxetine

Arm Intervention/treatment
Experimental: Deep Brain Stimulation
Continuous deep brain stimulation of bilateral nucleus accumbens
Procedure: Deep brain stimulation
Deep brain stimulation of bilateral nucleus accumbens
Other Name: DBS

Active Comparator: Standard Control
Fluoxetine
Other: Fluoxetine
Fluoxetine is one of selective serotonin reuptake inhibitors(SSRIs).




Primary Outcome Measures :
  1. BMI [ Time Frame: 6 month ]

Secondary Outcome Measures :
  1. weight [ Time Frame: 6 month ]
  2. Yale-Brown Obsessive Compulsive Scale [ Time Frame: 6 month ]
    Yale-Brown Obsessive Compulsive Scale(Y-BOCS) is used to evaluate obsessive compulsive symptom.

  3. Self-Rating Depression Scale [ Time Frame: 6 month ]
    Self-Rating Depression Scale(SDS) is used to evaluate depression symptom.

  4. The Symptom Checklist-90 [ Time Frame: 6 month ]
    The Symptom Checklist-90(SCL-90) is used to evaluate general status.



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Age between 18 and 65 years of age, male or female patients.
  2. Diagnosis is Anorexia Nervosa(AN) by the DSMIV(Diagnostic and Statistical Manual of Mental Disorders Fourth Edition).
  3. BMI<16.
  4. Long-term pharmacotherapy resistance.
  5. Written informed consent.
  6. normal intelligence and compliance

Exclusion Criteria:

  1. Surgical contradiction(implanted artificial cochlea、cardiac pacemaker、cardiac defibrillator、stereotactic ablative surgery、DBS)or receive other surgery which may influence this time of surgery in half year, or other neurosurgical contradictions; History of brain trauma;
  2. History of severe neuropsychiatric disease;
  3. Epilepsy;
  4. severe liver、kidney、heart and lung disease, severe hypertension and severe orthostatic hypotension;
  5. Severe diabetes ,severe cardiovascular and cerebrovascular disease;
  6. Malignant tumor;
  7. Being using anticoagulant or showing clinical hemorrhagic tendency; Pregnant female;
  8. Patients are taking part in other clinical trials in recent 3months; Being deem as unfit for the trials by researcher

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02593695


Locations
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China, Shaanxi
Department of neurosurgery, Tangdu Hospital
Xi'an, Shaanxi, China, 710038
Sponsors and Collaborators
Tang-Du Hospital
Investigators
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Principal Investigator: Guo-dong Gao, M.D. Department of neurosurgery, Tangdu Hospital

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Responsible Party: Guodong Gao, Neurosurgery Department, Tang-Du Hospital
ClinicalTrials.gov Identifier: NCT02593695     History of Changes
Other Study ID Numbers: ANDBS
First Posted: November 2, 2015    Key Record Dates
Last Update Posted: November 10, 2015
Last Verified: November 2015
Keywords provided by Guodong Gao, Tang-Du Hospital:
Anorexia Nervosa
Deep Brain Stimulation
Nucleus accumbens
Additional relevant MeSH terms:
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Anorexia
Anorexia Nervosa
Signs and Symptoms, Digestive
Signs and Symptoms
Feeding and Eating Disorders
Mental Disorders
Fluoxetine
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Serotonin Agents
Physiological Effects of Drugs
Antidepressive Agents, Second-Generation
Antidepressive Agents
Psychotropic Drugs
Cytochrome P-450 CYP2D6 Inhibitors
Cytochrome P-450 Enzyme Inhibitors
Enzyme Inhibitors